Xbox Kinect Training in Men With Prostate Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Hospitalsenheden Vest
Sponsor:
Information provided by (Responsible Party):
Brigitta R. Villumsen, Hospitalsenheden Vest
ClinicalTrials.gov Identifier:
NCT01762241
First received: December 20, 2012
Last updated: October 13, 2014
Last verified: October 2014

December 20, 2012
October 13, 2014
November 2014
June 2016   (final data collection date for primary outcome measure)
The effect of 12 weeks systematically training with the Xbox Kinect system on physical function [ Time Frame: Change from baseline in outcome measure after 12 weeks training ] [ Designated as safety issue: No ]
The effect of 12 weeks systematically training using the Nintendo Wii system measured using the Short Form - 36 (SF-36) subscale related to physical health. [ Time Frame: Change from baseline in outcome measures at 12 weeks training ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01762241 on ClinicalTrials.gov Archive Site
The effect of 12 weeks systematically training with the Xbox Kinect on body composition [ Time Frame: Change from baseline in outcome measure after 12 weeks training ] [ Designated as safety issue: No ]

Method:

Bioelectrical impedance

The effect of 12 weeks systematically training on quality of life and fatigue using the Nintendo Wii system. [ Time Frame: Change from baseline inoutcome measures at 12 weeks training ] [ Designated as safety issue: No ]

Methods:

European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30).

Functional assessment of chronic illness therapy - Fatigue/ FACIT - F. 6 minutes walk test. Isokinetic leg press from The University of Nottingham Medical School, Nottingham, United Kingdom.

  • The effect of 12 weeks systematically training with the Xbox Kinect system on fatigue [ Time Frame: Change from baseline in outcome measure after 12 weeks training ] [ Designated as safety issue: No ]
  • The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline in outcome measure after 12 weeks training ] [ Designated as safety issue: No ]
Not Provided
 
Xbox Kinect Training in Men With Prostate Cancer
Xbox Kinect Training in Men With Metastatic Prostate Cancer Receiving Androgen Deprivation Therapy

The purpose of this study is to investigate the effect of 12 weeks systematically training using the Xbox Kinect system.

Outcome measures are made on physical function, quality of life, fatigue and metabolic parameters.

Patients will be recruited from the outpatient clinic at the urological department, Regionshospitalet Holstebro.

Patients who have been discharged from the outpatient clinic due to biochemical stabile cancer prostate disease will receive a letter with information about the study.

A research assistant will be responsible for randomization and test procedures. A physiotherapist will be responsible for instruction of the participants to the training and the Xbox system.

A student will be responsible for installation and collection of the Xbox system in the participants home.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
Behavioral: Home based training using the Xbox Kinect system
Home based training 3 times a week for 12 weeks using the Xbox Kinect system
  • Experimental: Training using the Xbox Kinect system
    12 weeks systematically home based training 3 times per week one hour at the time using the Xbox Kinect system.
    Intervention: Behavioral: Home based training using the Xbox Kinect system
  • No Intervention: Control group
    No systematically training/standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
46
November 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prostate cancer requiring androgen deprivation therapy
  • Androgen deprivation therapy for at least 3 month prior to inclusion
  • Cognitive well-functioning in order to be able to answer questionnaires and train according to instructions
  • Signed informed consent

Exclusion Criteria:

  • Prostate cancer with metastasis to other regions than bones
  • Strength- or cardiovascular training 2 times or more per week prior to inclusion
  • Haemoglobin percentage less than 6,1 mmol/l
  • Any mental or physical condition that makes the patient unfit for participation
  • Men in risk of getting an osteoporotic fracture due to long-term treatment with steroids or earlier fractures due to minimal trauma
  • Participation in other studies
Male
40 Years and older
No
Contact: Brigitta R Villumsen, Ms.N. + 45 78439425 brigvill@rm.dk
Denmark
 
NCT01762241
Wii-1-10-72-593-12, 1-10-72-593-12
No
Brigitta R. Villumsen, Hospitalsenheden Vest
Hospitalsenheden Vest
Not Provided
Principal Investigator: Brigitta R Villumsen, M.S.N. Hospitalsenheden Vest
Hospitalsenheden Vest
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP